IMP Quality Manager

Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competences within the Interiman Group, we offer tailor-made solutions in personnel consulting.

For our client F. Hoffmann - La Roche in Basel, we are looking for a motivated and reliable (m/f/d)

IMP Quality Manager 80-100%

• Acts as a delegate of the Swiss RP for IMPs
• Has the QA responsibility for GMP compliance of manufacture and analysis of IMP batches (in particular parenteral drug product batches)
• Reviews and approves GMP procedures, records and reports (e.g. SOPs, master batch records, discrepancy and change records and validation reports)
• Performs self-inspections in GMP plants and laboratories at Roche Basel
• Reports directly to the RP and RP deputy

• Bachelor or Master Degree in Life Sciences or equivalent
• Min. 3 years of relevant experience in the pharmaceutical industry
• Min. 3 years experience in a GMP regulated environment
• Min. 3 years experience all activities around parenteral manufacturing and quality control
• Demonstrated experience in a Pharmaceutical Technical Development environment
• Knowledge of cGMP and Quality requirements for clinical development stages of biotechnological and/or parenteral IMPs (e.g. EU Annex 1)
• Experience in Discrepancy Management, CAPA, Technical Change Management (Veeva Vault) and Manufacturing Management (SAP), MES (PMX) and LIMS is an additional plus
• Fluent in English (C1) and German (C1), with clear and professional communication skills
• Fast learner, strong team player with a high level of self-motivation
• Proven ability to work independently and in a team towards results
• Excellent planning and organizing skills

• Project management skills
• Proficient contribution to health authority inspections and internal GMP audits

Are you interested and would you like to seize this opportunity? Then we should definitely get to know each other!  Simply click on "Apply now" and we look forward to receiving your complete application documents.